The Recall Desk

Hazard

Dissolution Failure recalls

270 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
270
Critical
0
Severe
10
Most recent
2026-09-02

Of the 270 dissolution failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (4%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all dissolution failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 270

  • ModerateFDA (Drugs)·D-0804-2026·2026-09-02

    Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing

    Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0774-2026·2026-08-26

    Mylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure

    Mylan Pharmaceuticals is recalling Acamprosate Calcium tablets that failed to meet dissolution specifications.

    Product
    ACAMPROSATE CALCIUM — ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2026·2026-06-17

    Niacin extended-release tablets failed dissolution testing at 24 hours

    GSMS Niacin Extended-Release Tablets, USP, 1,000 mg, are being recalled after a lot was out of specification for stage 3 dissolution at the 24-hour timepoint. 2,961 bottles affected.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0597-2026·2026-06-17

    Minocycline extended-release tablets failed dissolution testing during stability analysis

    Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.

    Product
    MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2025·2025-08-20

    Theophylline extended-release tablets failed dissolution at long-term stability testing

    Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0584-2025·2025-08-20

    Belsomra 10 mg tablets failed dissolution, which may delay sleep onset

    Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.

    Product
    BELSOMRA — BELSOMRA (SUVOREXANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2025·2025-07-23

    Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability

    Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2025·2025-06-18

    Chlorthalidone Tablets Recalled Due to Failed Dissolution Specifications

    AvKARE is recalling Chlorthalidone Tablets USP 25 mg due to failed dissolution specifications. The defect may affect the drug's therapeutic effectiveness.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0304-2025·2025-04-09

    Tolterodine Tartrate Extended-Release Capsules Recalled for Failed Dissolution

    Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393) are being recalled because they failed dissolution specifications. The capsules may not dissolve as intended.

    Product
    Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2025·2025-03-26

    FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications

    Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2025·2025-02-19

    Irbesartan Tablets Recalled Due to Out-of-Specification Dissolution

    AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2025·2025-02-12

    Potassium Chloride Tablets Recalled for Failed Dissolution Specifications

    The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2025·2025-01-22

    FDA recalls glipiZIDE Extended-Release Tablets for failed dissolution specifications

    Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.

    Product
    glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0187-2025·2025-01-15

    Colchicine Capsules Recalled Due to Failed Dissolution Specifications

    Granules Pharmaceuticals is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications detected during stability testing. Patients should contact their healthcare provider for guidance.

    Product
    COLCHICINE — COLCHICINE (COLCHICINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2025·2025-01-08

    AvKARE Nitrofurantoin 100 mg Capsules Recalled for Dissolution Failures

    AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.

    Product
    Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2024·2024-10-02

    Prescription immunosuppressant tablets recalled due to failed dissolution specifications

    Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

    Product
    MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0619-2024·2024-08-07

    Potassium Chloride Extended-Release Capsules Recalled Over Failed Dissolution

    Amerisource Health Services LLC is recalling 61,231 bottles of Potassium Chloride Extended-Release Capsules nationwide due to failed dissolution specifications. The medication may not release properly, potentially affecting dosing accuracy.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2024·2024-07-31

    Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications

    Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2024·2024-07-24

    Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    Distribution
    Distributed nationwide